Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

A Randomised Control Trial of Rehabilitation With or Without a Knee Orthosis Following Meniscal Repair

RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.

Study Overview

• Status: Recruiting
• Conditions: Meniscal Tear
• Intervention / Treatment: Other: Standard rehab; Other: accelerated rehab group

Detailed Description

The purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. There is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with ACLR. Many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. Some also avoid weight baring and crouching for various periods of time. This is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. There is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with ACLR does not compromise meniscal healing. There is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure.

The study design is a prospective randomized study with equal groups.

A power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. Randomisation will continue until 60 patients are allocated to both groups.

Randomization process and study design will be done according to the CONSORT guidelines.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian D McCallum, MBBS; Phone Number: +46760393379; Email: mccallum.seb@gmail.com
• Study Contact Backup: Name: Christoffer Von Essen, MD; Email: christoffer.vonessen@capio.se

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Recruiting
    • Karolinska University Hospital
    • Contact: Anders Stålman, MD PhD; Phone Number: +46736994573; Email: anders.stalman@ki.se
    • Principal Investigator: Anders Stålman, MD, PhD
  • Stockholm, Sweden, 11427
    • Recruiting
    • Centrum för idrottsforskning och utbildning (CIFU)
    • Contact: Anders Stålman; Phone Number: +46736665957; Email: anders.stalman@ki.se
    • Principal Investigator: Sebastian McCallum, MD
    • Principal Investigator: Erik Rönnblad, PhD
    • Principal Investigator: Christoffer Von Essen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.

Exclusion Criteria:

• Associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury.
• Previous meniscal repair in the affected meniscus
• BMI over 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard rehab group; This group will follow the clinics standard rehab protocol, wherein they have a knee orthosis for six weeks, with flexion limited to 0-30 degress week 0-2, 0-60 degrees week 2-4 and 0-90 degrees week 4-6. Crouching is not permitted week 6-12.	Other: Standard rehab; Standard rehab protocol including knee orthosis following meniscal repair
Active Comparator: Accelerated rehab group; accelerated rehab group, wherein they are permitted to perform range of motion training within their comfort zone. Running is permitted after 8 weeks, contact sports 4 months postoperatively	Other: accelerated rehab group; accelerated rehab group, no orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Biodex isokinetic quadriceps strength at 6 months	Patients will undergo Biodex Isokinetic measurement at 6 months	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of failure	Rates of failure, defined as reoperation with meniscal resection within two years of the repair.	two years
Knee injury and Osteoarthritis Outcome Score (KOOS)	Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results	preoperative, six months, two years
Change from baseline Biodex isokinetic quadriceps strength at 24 months	Patients will undergo Biodex Isokinetic measurement at 24 months	2 years
Goniometric measurement: Knee flexion and extension	Patients will undergo Goniometric measurement at specific time points to evaluate knee range of motion	2 weeks, 6 weeks, 6 months, 2 years
IKDC	Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results	Pre-operative, 6 months, 2 years
Tegner activity score	Patients will complete the Tegner activity score at specific time points to evaluate Activity in sports throughout treatment, Assesses activity level with specific emphasis on knee; scores range from 1 (least strenuous activity) to 10 (high knee demanding activity on professional sports level)	Pre-operative, 6 months, 2 years
Lysholm score	Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment. Score range from 0 to 100, with higher scores indicating better results	Pre-operative, 6 months, 2 years
Measurement of circumference of the knee	Circumference of the knee will be measured at mid-patella and 15cm above superior border of patella. They will be compared with contralateral knee to compare swelling.	Pre-operative, 6 weeks, 3 months, 6 months, 2 years
Functional knee tests	patients will undergo functional knee tests (ie Single hop test for difference, 30s chair-stand test	6 weeks, 6 months, 2 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Director: Erik Rönnblad, Centrum för idrottsforskning och utbildning (CIFU) Adress: Valhallavägen 91, 11427 Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Meniscal suture orthosis study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No